Galenica AB’s new pharmaceutical product for treatment of Psoriasis and Eczema, Ovixan®, received on Thursday the 15th of December a positive review by Nordic Authorities.

Malmö-based Galenica informs that Ovixan® received approval in the decentralized procedure involving all Nordic countries, and can now proceed to national step for granting Market Authorization. Reporting countries are Sweden, Norway, Denmark, Finland and Iceland.

Galenica CEO Ronnie Wallin comments the news of approval:

“We have been looking forward to this day for many years and are very pleased to have reached this stage. What’s left is the Market Authorization from each of the Nordic Countries. However, we still have a long way to go before we reach our main goal; to be able to grant Psoriasis and Eczema patients the use of Ovixan®.”

For further information, please contact:

Ronnie Wallin, CEO Galenica AB
T +46 708 21 11 22
email: Ronnie.wallin@galenica.se

Joakim Hindemith, Business Unit Director Galenica AB
T +46 722 49 71 00
email: Joakim.hindemith@galenica.se

We want to make a difference to the world we live in not just by what we do in our daily activities, but also by social responsibility.

Each year Barncancerfonden fund 90% of child cancer research in Sweden without any support from the government.
The business is entirely dependent on voluntary support from individuals and companies. In addition to research, Barncancerfonden fund childhood cancer care, health care development, support to affected families, and information dissemination. All in all, designed to create the best conditions to achieve the overall goal: helping all children affected by cancer to become healthy again and to enjoy life to its full extent.

Consequently, there are continuous efforts in clinical trials supplies to make the handling safer and the logistics more reliable. The aim is to ensure that each site and each patient is supplied with the right medication, in the right quantity at the right time.

NEW: Packing and labeling
Risks can, of course, be reduced in many different ways. One way to enhance control and ease management concerns is simply by decreasing the number of players involved in the supply chain. As a part of this effort, we at Galenica recently decided to extend our offering to also include packaging and labeling of clinical trials supplies and we now fulfill all relevant regulatory standards and have acquired the necessary permissions.

Keeping some of the work stages within our own premises bring several improvements to the operations. Naturally, it is easier to supervise and control all details if the packaging and labeling process takes place in-house and can be executed in one single uninterrupted sequence. This is especially valuable if the trials are complex and distributed over both time and space.

Being able to avoid shipping to and from another Contract Research Organization in charge of packaging and/or labeling has several advantages. Not only will it decrease the risk of goods getting mixed-up or instructions being misunderstood. In addition, each transport means that the medicinal preparations will leave a closely monitored indoor climate and risk – by negligence, lack of judgment or bad luck – being exposed to cold, heat, humidity or careless handling.

These measures and procedures do not make our system absolutely foolproof, but it takes our clients one step closer to trials without errors.

Continuously growing in scope and stature, this international exhibition now attracts tens of thousands of professionals from thousands of pharmaceutical companies in countries all over the world, making it at “must attend” for anyone set on keeping up with the latest developments, trends and news in the business.

Galenica will, of course, be there. Like many other exhibitors we recognize this as a golden opportunity to promote our products and services, find new leads and, eventually, expand our business.

But that is not our only purpose. To expand and manage ones network is just as important. We therefore hope to repeat last year’s success in Paris, where we had many fruitful meetings and discussions with customers, partners, colleagues and competitors from different parts of the industry.

Do you want to meet us at the conference? Please feel free to contact us at Galenica in advance, or drop by our exhibition booth – 41H60 – for a friendly chat or to set up a business meeting.

Yet, from time to time eagerness and impatience gets the better of customers. “How long will an analysis take?” they ask, implying that it cannot possibly be very time-consuming.

Well it isn’t, at least as long as we just talk about running a single sample through analytical equipment. But there is more to the process than just that. Analysis could, with slight exaggeration, be compared to landing on the moon – even if the final descent and touchdown on the lunar surface is accomplished in a matter of moments, anyone understands that it takes lots of detailed planning and thorough preparations before you get there.

This is true also for pharmaceutical analysis.

Successful analysis depends on a number of factors, from choosing the correct laboratory equipment and making sure it works as intended to securing that the final data is correctly interpreted and accounted for.

Much effort is usually put into developing and validating new analytical methods. This is almost always a prerequisite to be able to identify impurities and degradation products in the samples. Other tasks, such as finding the right solvent, can be a snag. Use of well characterized reference standards is also an important component, and, finally, systematic evaluation and documentation of the test results must also be considered an integral part of analytical services.

All these different aspects should, of course, be taken into account when estimating the time needed to make a complete pharmaceutical analysis. At Galenica we have the expertise and the knowledge necessary to support a wide variety of such development projects. After all, we don’t think our clients are asking for the moon.

Analytical service is no exception.

Now, let’s look at some of the issues and challenges that are significant for pharmaceutical analytical chemistry.

Characterization of a new active pharmaceutical ingredient, API, requires a battery of methods and techniques. To analyze how the very same API works, responds or degrades in a formulation, normally calls for a totally different toolbox.

Running an analysis on API alone is a quite straightforward operation because the sample is very pure. After formulation, on the other hand, the API must be extracted before it can be analyzed. This can sometimes be a rather tricky and time consuming operation, highly dependent on dosage form.

The chemical stability must be studied to determine, for instance, the expected shelf-life of the drug. To do so, samples must be taken, in which all of the API as well as all possible degradation products are accounted for with high accuracy.

All excipients have an impact on the API. A combination of two or more excipients can produce yet another response that will affect the stability or efficacy of the medication. Even though many APIs are similar and have common chemical traits, each and everyone require its own analysis. Likewise, any change in the mix of excipients may introduce new analytical challenges.

The fine art of pharmaceutical analysis is not so much a question of knowing what kind or how much of an API that goes into a formulation, but rather making sure that all of it always can be traced at any time.

At Galenica we believe that it is important for a company to be as open and transparent as business admits. We are convinced that in the long run it pays off to be generous and freely share ideas, experiences and knowledge. This is one of the main reasons we decided to start a company blog.

And we are happy to notice that we are not alone in this belief.

When the magazine Swedish Biotech (only available in Swedish, unfortunately) recently interviewed the CEO of Cellavision in Lund, Yvonne Mårtensson, on why her company has started a blog and an Iphone application, her answer can be summarized as follows:

It is a way for us to reach out with industry-related materials to a broader group, partners as well as media and our end customers, who are all over the world. With the blog as an information channel, we can have a dialogue with our customers … since the material is scientifically based, we enhance our credibility in the market.

Well put, Yvonne.

Audits and inspections are common, not only because the pharmaceutical industry is closely regulated by national authorities, but also since buyers have an obligation to audit their subcontractors. Hence, our operations are more or less constantly being evaluated by existing or potential clients.

The general objective for all audits is to assure that the subcontractor’s products or services are up to standards and fulfill the required quality. Basically every aspect of the operations is scrutinized – from general production processes and procedures for documentation to the expertise and experience of the personnel and the quality of the premises and equipment. Results and issues are then penetrated in close collaboration with the client and, if need be, addressed in a suitable manner.

Yet, not two audits are identical. There is no blueprint for this process, so all clients have somewhat different requirements depending on the nature of their project.

Having our business meticulously examined from almost every imaginable angle forces us to consider and re-consider how we plan, organize, execute and document all our work and processes. A single audit seldom brings about great or revolutionary changes in the way the operations are run. But they regularly generate improvements; small steps in the continuous efforts to enhance and secure the quality in our offering.

Audits can never be regarded as a burden or a nuisance. On the contrary, without the frequent audits it would be a lot more difficult to reach the high standards and great quality our clients expect from us.

Success. There is no better word to summarize the ISCE exhibition, which recently took place at the Paris Nord Villepinte exhibition centre in the French capital.

Representatives from Galenica were there among several thousand exhibitors and visitors. In our booth and across the huge exhibition hall we had many interesting encounters and discussions with customers, partners, colleagues and competitors from different parts of the pharmaceutical industry.

Once again this annual three day event proved a golden opportunity to keep up with the latest trends and practices of the industry as well as to discover and explore new customer contacts. We left the ISCE exhibition not only with plenty of new valuable knowledge, experience and ideas but also with several promising leads – some of which already have developed into closer collaboration and joint projects.

Needless to say, Galenica will be back at the ISCE exhibition next year.

See you in Frankfurt in October 2011.

Even if a pharmaceutical substance shows good potential, the decision to move on from laboratory experiments does not always come lightly. Going forward with testing, formulation and, eventually, clinical trials usually means that the project quickly will get a lot bigger, more complex, involve more people as well as greater financial risks. As a consequence administration can also become burdensome.

This is a challenge – not only for smaller clients with limited resources. So some hesitation at this point is therefore completely understandable. Fortunately, many of the obstacles can be avoided. Efficient project management and skilled project managers pave the way to successful pharmaceutical formulation.

Over the years, we at Galenica have acquired thorough knowledge on how to scale up projects without disrupting or slowing down the development process. We pride ourselves in forming highly qualified, efficient and focused project teams with dedicated project managers who keep projects on track and within time limits.

Our project managers work closely with their clients, keeping communication lines open at all times, setting up meetings and proactively monitoring the project. They are also used to coordinate contacts within an extensive network of third parties, such as raw material providers, subcontractors, consultants, etc.

Proper planning and careful preparations ensure that things run efficiently during the entire project and that best quality possible is acquired in every step. Experience from numerous different projects enables us to contribute with creative solutions, thoughts and ideas. Finally, with organizational skills it is easier to prevent budget overdrafts and make sure that documentation and other paper work never lag behind.

We know that successful project management is about setting firm, but realistic, targets and deadlines. And we make sure that they are met.